All weeks
Drybench Patent.
Changes to FDA's patent and exclusivity files, week of 26 October 2026
11 rows changed in purplebook.csv: 5 added, 0 removed, 6 changed.
FDA capture · review pending. Each week compares the dated FDA files mechanically, capture to capture, and any row shown is transcribed as FDA lists it. The rule interpretations and fixtures have not been independently reviewed by a regulatory-affairs reviewer.
Partial: captures to 30 October 2026.
- Week
- 26 October 2026 to 1 November 2026
- Captures held
- To 30 October 2026
- Store built
- 31 October 2026
Rows as FDA lists them, not a forecast of market entry and not legal, regulatory or investment advice.
- The Purple Book changes of 30 October 2026 are recomputed by BLA number and product number. The capture first recorded them with an earlier key that paired different products of one BLA; that record is kept unchanged on the data branch.
Purple Book purplebook.csv
Ahzantive (aflibercept-mrbb)
aflibercept-mrbb · BLA 761378 · product 003
30 October 2026 · Row added
- N/R/U
- N
- Applicant
- Formycon AG
- BLA Number
- 761378
- Proprietary Name
- Ahzantive
- Proper Name
- aflibercept-mrbb
- License Type
- 351(k) Interchangeable
- Strength
- 2MG/0.05ML
- Dosage Form
- Injection
- Route of Administration
- Intravitreal
- Product Presentation
- Pre-Filled Syringe
- Marketing Status
- Rx
- Licensure
- Licensed
- Approval Date
- April 17, 2025
- Inter. Approval Date
- October 22, 2026
- Ref. Product Proper Name
- aflibercept
- Ref. Product Proprietary Name
- Eylea
- Supplement Number
- 1
- Submission Type
- Supplement
- Inter. Supplement Number
- 2
- License Number
- 2322
- Product Number
- 003
- Center
- CDER
- Date of First Licensure
- blank
- Exclusivity Expiration Date
- blank
- First Interchangeable Exclusivity Exp. Date
- blank
- Ref. Product Exclusivity Exp. Date
- blank
- Orphan Exclusivity Exp. Date
- blank
- Patent List Provided
- blank
Open in the appCitation
- File
- purplebook.csv
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
- Row as captured
- N,Formycon AG,761378,Ahzantive,aflibercept-mrbb,351(k) Interchangeable,2MG/0.05ML,Injection ,Intravitreal,Pre-Filled Syringe,Rx,Licensed,"April 17, 2025","October 22, 2026",aflibercept,Eylea,1,Supplement,2,2322,003,CDER,,,,,,
30 October 2026 · Changed
- N/R/U
- blank U
- License Type
- 351(k) Biosimilar 351(k) Interchangeable
- Inter. Approval Date
- blank October 22, 2026
Open in the appCitation
- File
- purplebook.csv
- Row key
- BLA 761378 · product 001
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Enzeevu (aflibercept-abzv)
aflibercept-abzv · BLA 761382 · product 003
30 October 2026 · Row added
- N/R/U
- N
- Applicant
- Sandoz Inc.
- BLA Number
- 761382
- Proprietary Name
- Enzeevu
- Proper Name
- aflibercept-abzv
- License Type
- 351(k) Interchangeable
- Strength
- 2MG/0.05ML
- Dosage Form
- Injection
- Route of Administration
- Intravitreal
- Product Presentation
- Pre-Filled Syringe
- Marketing Status
- Rx
- Licensure
- Licensed
- Approval Date
- August 9, 2024
- Inter. Approval Date
- October 22, 2026
- Ref. Product Proper Name
- aflibercept
- Ref. Product Proprietary Name
- Eylea
- Submission Type
- Original
- License Number
- 2003
- Product Number
- 003
- Center
- CDER
- Date of First Licensure
- blank
- Exclusivity Expiration Date
- blank
- First Interchangeable Exclusivity Exp. Date
- blank
- Ref. Product Exclusivity Exp. Date
- blank
- Orphan Exclusivity Exp. Date
- blank
- Patent List Provided
- blank
Open in the appCitation
- File
- purplebook.csv
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
- Row as captured
- N,Sandoz Inc.,761382,Enzeevu,aflibercept-abzv,351(k) Interchangeable,2MG/0.05ML,Injection ,Intravitreal,Pre-Filled Syringe,Rx,Licensed,"August 9, 2024","October 22, 2026",aflibercept,Eylea,,Original,,2003,003,CDER,,,,,,
30 October 2026 · Changed
- N/R/U
- blank U
- License Type
- 351(k) Biosimilar 351(k) Interchangeable
- Inter. Approval Date
- blank October 22, 2026
Open in the appCitation
- File
- purplebook.csv
- Row key
- BLA 761382 · product 001
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Gonal-f (follitropin alfa)
follitropin alfa · BLA 020378 · product 004
30 October 2026 · Changed
- N/R/U
- blank U
- Marketing Status
- Rx Disc
- Licensure
- Licensed Voluntarily Revoked
Open in the appCitation
- File
- purplebook.csv
- Row key
- BLA 020378 · product 004
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Lucamzi (ranibizumab-blrz)
ranibizumab-blrz · BLA 761187 · product 001
30 October 2026 · Row added
- N/R/U
- N
- Applicant
- Xbrane Biopharma AB
- BLA Number
- 761187
- Proprietary Name
- Lucamzi
- Proper Name
- ranibizumab-blrz
- License Type
- 351(k) Biosimilar
- Strength
- 10MG/ML (0.5MG/0.05ML)
- Dosage Form
- Injection
- Route of Administration
- Intravitreal
- Product Presentation
- Single-Dose Vial
- Marketing Status
- Rx
- Licensure
- Licensed
- Approval Date
- October 27, 2026
- Inter. Approval Date
- blank
- Ref. Product Proper Name
- ranibizumab
- Ref. Product Proprietary Name
- Lucentis
- Submission Type
- Original
- License Number
- 2207
- Product Number
- 001
- Center
- CDER
- Date of First Licensure
- blank
- Exclusivity Expiration Date
- blank
- First Interchangeable Exclusivity Exp. Date
- blank
- Ref. Product Exclusivity Exp. Date
- blank
- Orphan Exclusivity Exp. Date
- blank
- Patent List Provided
- blank
Open in the appCitation
- File
- purplebook.csv
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
- Row as captured
- N,Xbrane Biopharma AB,761187,Lucamzi,ranibizumab-blrz,351(k) Biosimilar,10MG/ML (0.5MG/0.05ML),Injection ,Intravitreal,Single-Dose Vial,Rx,Licensed,"October 27, 2026",,ranibizumab,Lucentis,,Original,,2207,001,CDER,,,,,,
Pavblu (aflibercept-ayyh)
aflibercept-ayyh · BLA 761298 · product 003
30 October 2026 · Row added
- N/R/U
- N
- Applicant
- Amgen Inc.
- BLA Number
- 761298
- Proprietary Name
- Pavblu
- Proper Name
- aflibercept-ayyh
- License Type
- 351(k) Interchangeable
- Strength
- 2MG/0.05ML
- Dosage Form
- Injection
- Route of Administration
- Intravitreal
- Product Presentation
- Pre-Filled Syringe
- Marketing Status
- Rx
- Licensure
- Licensed
- Approval Date
- August 23, 2024
- Inter. Approval Date
- October 22, 2026
- Ref. Product Proper Name
- aflibercept
- Ref. Product Proprietary Name
- Eylea
- Submission Type
- Original
- License Number
- 1080
- Product Number
- 003
- Center
- CDER
- Date of First Licensure
- blank
- Exclusivity Expiration Date
- blank
- First Interchangeable Exclusivity Exp. Date
- blank
- Ref. Product Exclusivity Exp. Date
- blank
- Orphan Exclusivity Exp. Date
- blank
- Patent List Provided
- blank
Open in the appCitation
- File
- purplebook.csv
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
- Row as captured
- N,Amgen Inc.,761298,Pavblu,aflibercept-ayyh,351(k) Interchangeable,2MG/0.05ML,Injection ,Intravitreal,Pre-Filled Syringe,Rx,Licensed,"August 23, 2024","October 22, 2026",aflibercept,Eylea,,Original,,1080,003,CDER,,,,,,
30 October 2026 · Changed
- N/R/U
- blank U
- License Type
- 351(k) Biosimilar 351(k) Interchangeable
- Inter. Approval Date
- blank October 22, 2026
Open in the appCitation
- File
- purplebook.csv
- Row key
- BLA 761298 · product 001
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Poherdy (pertuzumab-dpzb)
pertuzumab-dpzb · BLA 761450 · product 001
30 October 2026 · Changed
- N/R/U
- blank U
- First Interchangeable Exclusivity Exp. Date
- Date TBD July 30, 2027
Open in the appCitation
- File
- purplebook.csv
- Row key
- BLA 761450 · product 001
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Yesafili (aflibercept-jbvf)
aflibercept-jbvf · BLA 761274 · product 003
30 October 2026 · Row added
- N/R/U
- N
- Applicant
- Biocon Biologics Inc.
- BLA Number
- 761274
- Proprietary Name
- Yesafili
- Proper Name
- aflibercept-jbvf
- License Type
- 351(k) Interchangeable
- Strength
- 2MG/0.05ML
- Dosage Form
- Injection
- Route of Administration
- Intravitreal
- Product Presentation
- Pre-Filled Syringe
- Marketing Status
- Rx
- Licensure
- Licensed
- Approval Date
- January 13, 2026
- Inter. Approval Date
- October 22, 2026
- Ref. Product Proper Name
- aflibercept
- Ref. Product Proprietary Name
- Eylea
- Supplement Number
- 1
- Submission Type
- Supplement
- Inter. Supplement Number
- 6
- License Number
- 2324
- Product Number
- 003
- Center
- CDER
- Date of First Licensure
- blank
- Exclusivity Expiration Date
- blank
- First Interchangeable Exclusivity Exp. Date
- blank
- Ref. Product Exclusivity Exp. Date
- blank
- Orphan Exclusivity Exp. Date
- blank
- Patent List Provided
- blank
Open in the appCitation
- File
- purplebook.csv
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
- Row as captured
- N,Biocon Biologics Inc.,761274,Yesafili,aflibercept-jbvf,351(k) Interchangeable,2MG/0.05ML,Injection ,Intravitreal,Pre-Filled Syringe,Rx,Licensed,"January 13, 2026","October 22, 2026",aflibercept,Eylea,1,Supplement,6,2324,003,CDER,,,,,,
Yuflyma (adalimumab-aaty)
adalimumab-aaty · BLA 761219 · product 006
30 October 2026 · Changed
- N/R/U
- blank U
- Marketing Status
- Rx Disc
Open in the appCitation
- File
- purplebook.csv
- Row key
- BLA 761219 · product 006
- Capture date
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Changed only in the N/R/U column: 17 rows
FDA's release-status marker cleared between releases; not a listing change, and not counted above.
- Byooviz (ranibizumab-nuna)ranibizumab-nuna · BLA 761202 · product 002N/R/U N blank
- Degevma (denosumab-adet)denosumab-adet · BLA 761481 · product 001N/R/U N blank
- Entyvio (vedolizumab)vedolizumab · BLA 761133 · product 001N/R/U U blank
- Entyvio Pen (vedolizumab)vedolizumab · BLA 761133 · product 002N/R/U U blank
- Garzulys (insulin aspart-fsan)insulin aspart-fsan · BLA 761497 · product 001N/R/U U blank
- Garzulys (insulin aspart-fsan)insulin aspart-fsan · BLA 761497 · product 002N/R/U U blank
- Isembyld (apitegromab-mstn)apitegromab-mstn · BLA 761463 · product 001N/R/U N blank
- N/A (raxibacumab)raxibacumab · BLA 125349 · product 001N/R/U U blank
- Onswik (insulin efsitora alfa-gobe)insulin efsitora alfa-gobe · BLA 761408 · product 001N/R/U N blank
- Onswik (insulin efsitora alfa-gobe)insulin efsitora alfa-gobe · BLA 761408 · product 002N/R/U N blank
- Tevimbra (tislelizumab-jsgr)tislelizumab-jsgr · BLA 761232 · product 001N/R/U U blank
- Tevimbra (tislelizumab-jsgr)tislelizumab-jsgr · BLA 761232 · product 002N/R/U N blank
- Yusimry (adalimumab-aqvh)adalimumab-aqvh · BLA 761216 · product 001N/R/U U blank
- Yusimry (adalimumab-aqvh)adalimumab-aqvh · BLA 761216 · product 002N/R/U U blank
- Yusimry (adalimumab-aqvh)adalimumab-aqvh · BLA 761216 · product 003N/R/U N blank
- Yusimry (adalimumab-aqvh)adalimumab-aqvh · BLA 761216 · product 004N/R/U N blank
- Zorbtive/Serostim (somatropin)somatropin · BLA 020604 · product 004N/R/U U blank